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Low-dose paroxetine 7.5 mg for menopausal vasomotor symptoms: two randomized controlled trials

Simon, James A. MD, CCD, NCMP, IF, FACOG1; Portman, David J. MD2; Kaunitz, Andrew M. MD3; Mekonnen, Hana MA4; Kazempour, Kazem PhD4; Bhaskar, Sailaja PhD5; Lippman, Joel MD5

doi: 10.1097/GME.0b013e3182a66aa7
Original Study
OPEN Access

Objective: The efficacy and safety of low-dose paroxetine 7.5 mg for the treatment of menopausal vasomotor symptoms were evaluated in two multicenter, double-blind, placebo-controlled, phase 3 studies of 12 and 24 weeks’ duration.

Methods: Postmenopausal women were randomly assigned 1:1 to receive paroxetine 7.5 mg or placebo once daily. The four primary efficacy endpoints included mean changes in the frequency and severity of moderate to severe vasomotor symptoms on weeks 4 and 12; an additional endpoint was persistence of treatment benefit on week 24.

Results: Five hundred ninety-one participants were randomly assigned to treatment with paroxetine 7.5 mg, and 593 participants were randomly assigned to treatment with placebo. All primary endpoints were met in the 24-week study; three of four primary endpoints were met in the 12-week study. In both studies, paroxetine 7.5 mg significantly reduced the mean weekly vasomotor symptom frequency compared with placebo on week 4 (P < 0.0001 for both studies) and week 12 (P = 0.0090, 12-wk study; P = 0.0001, 24-wk study). Mean weekly reduction in vasomotor symptom severity was significantly greater for paroxetine 7.5 mg than for placebo on week 4 (P = 0.0048) in the 12-week study and on week 4 (P = 0.0452) and week 12 (P = 0.0114) in the 24-week study. Persistence of treatment benefit was demonstrated in the 24-week study. Most treatment-emergent adverse events were mild or moderate in severity. No clinically significant changes in laboratory values or vital signs were noted, and no short-term discontinuation of symptoms followed treatment cessation.

Conclusions: Paroxetine 7.5 mg is well-tolerated, is effective in reducing the frequency and severity of menopausal vasomotor symptoms, and demonstrates persistence of treatment benefit through 24 weeks of treatment.

From the 1George Washington University School of Medicine and Women’s Health and Research Consultants, Washington, DC; 2Columbus Center for Women’s Health Research, Columbus, OH; 3University of Florida College of Medicine, Jacksonville, FL; 4Amarex Clinical Research, Germantown, MD; and 5Noven Pharmaceuticals Inc, New York, NY.

Received May 30, 2013; revised and accepted July 23, 2013.

Funding/support: These studies ( identifiers NCT01361308 and NCT01101841) were funded by Noven Pharmaceuticals Inc (New York, NY). Editorial assistance was likewise funded by Noven Pharmaceuticals Inc.

Financial disclosure/conflicts of interest: J.A.S. has served (in the last year) or is currently serving as consultant to or on the advisory boards of Abbott Laboratories/AbbVie Inc (North Chicago, IL), Agile Therapeutics Inc (Princeton, NJ), Amgen Inc (Thousand Oaks, CA), Apotex Inc (Toronto, Canada), Ascend Therapeutics (Herndon, VA), BioSante (Lincolnshire, IL), Depomed Inc (Menlo Park, CA), Everett Laboratories Inc (West Orange, NJ), Intimina by Lelo Inc (San Jose, CA), Lupin Pharmaceuticals (Baltimore, MD), MD Therapeutics (Boca Raton, FL), Meda Pharmaceuticals Inc (Somerset, NJ), Merck (Whitehouse Station, NJ), Noven Pharmaceuticals Inc, Novo Nordisk (Bagsværd, Denmark), Novogyne (East Hanover, NJ), Pfizer Inc (New York, NY), Shionogi Inc (Florham Park, NJ), Shippan Point Advisors LLC (Upper Saddle River, NJ), Slate Pharmaceuticals Inc (Durham, NC), Sprout Pharmaceuticals (Raleigh, NC), Teva Pharmaceutical Industries Ltd (Jerusalem, Israel), Warner Chilcott (Rockaway, NJ), and Watson PharmaceuticalInc (Corona, CA). He has received or is currently receiving grant/research support from Abbott Laboratories/AbbVie Inc, BioSante, EndoCeutics Inc (Quebec, Canada), Novo Nordisk, Novogyne, Palatin Technologies (Cranbury, NJ), Teva Pharmaceutical Industries Ltd, and Warner Chilcott. He has also served or is currently serving on speakers’ bureaus for Amgen Inc, Eisai Inc (Woodcliff Lake, NJ), Merck, Novartis (Basel, Switzerland), Noven Pharmaceuticals Inc, Novo Nordisk, Novogyne, Shionogi Inc, Teva Pharmaceutical Industries Ltd, and Warner Chilcott. J.A.S. served as chief medical officer at Sprout Pharmaceuticals.

D.J.P. has served on the speakers’ bureau for Noven Pharmaceuticals Inc, from which he has also received research grant support and consulting fees. He has served on the advisory board of and the speakers’ bureau for Teva Pharmaceutical Industries Ltd, from which he has also received research grant support and payment for educational presentations and travel expenses. D.J.P. has received research support from Depomed Inc and Pfizer Inc and has served on the speakers’ bureau for Warner Chilcott. He has also served as consultant to Meda Pharmaceuticals Inc. A.M.K. has served on the board of The North American Menopause Society (Mayfield Heights, OH) and has received consultancy fees from Bayer AG (Leverkusen, Germany), Depomed Inc, Merck, and Noven Pharmaceuticals Inc. The Department of Obstetrics and Gynecology at the University of Florida College of Medicine (Jacksonville, FL) has received grants from EndoCeutics Inc, Bayer AG, Teva Pharmaceutical Industries Ltd, and Noven Pharmaceuticals Inc. H.M. and K.K. have no conflicts of interest to disclose. S.B. and J.L. are employees of Noven Pharmaceuticals Inc.

Address correspondence to: James A. Simon, MD, CCD, NCMP, IF, FACOG, Department of Obstetrics and Gynecology, George Washington University, and Women’s Health and Research Consultants, Suite 450, 1850 M Street, NW, Washington, DC 20036. E-mail:

© 2013 by The North American Menopause Society.